Senior Scientist, Analytical Development and Quality Control - Early Phase
$162k - $186kScorpion Therapeutics
Responsibilities: Lead DP analytical method development, validation, and lifecycle management for ASDs and lipid-based formulations. Support PPQ, commercialization, commercial QC, and lifecycle management for analytical methods and control strategies. Design/oversee DP development, registration batch, and commercial stability programs (protocols, trend analysis). Author/review DP analytical development reports to support IND/IMPD/NDA submissions and marketing authorization. Oversee analytical activities (method development, validation, QC testing) at CDMOs and CTLs. Contribute to investigations (OOS/OOE/OOT), root cause analysis, and CAPAs. Critically review analytical data, protocols, reports, specifications, and documentation. Trend stability data; support retest periods and shelf-life using statistical methods. Collaborate on material control strategies and specifications. Author technical documentation (validation/stability protocols/reports, specifications, COAs, storage statements) and health authority responses. Maintain analytical documentation for traceability, data integrity, and inspection readiness; follow cGMP/SOPs. Travel up to 5% as required. Qualifications: Advanced degree in Chemistry, Pharmaceutics, or related field. Senior Scientist: BS/MS with 14+ years or PhD with 8+ years industrial CMC experience. Strong DP analytical development/validation experience; expertise with ASDs and/or lipid-based formulations. CDMO/contract testing lab oversight experience. Experience supporting regulatory submissions (IND/IMPD/NDA) and global filings. ICH, cGMP, and pharmacopeial chapter fluency; cross-functional collaboration. Strong technical writing and ability to manage multiple priorities. Salary Range: $162K–$186K #J-18808-Ljbffr Scorpion Therapeutics
Vacancy posted 3 days ago
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